Kornimate/medical-research-clean huggingface dataset:
orsiro stents versus xience prime stents assessed by optical coherence tomography

Conditions: Coronary Heart Disease

Summary: this prospective, randomized trial will compare the extent of covered stent strut segments by assessed by optical coherence tomography (oct) of the orsiro des with that of the xience prime des, which is the standard of choice of contemporary drug eluting stents (des).

the orsiro drug eluting stent exhibits a favourable vascular healing profile from baseline to 6 months assessed by optical coherence tomography (oct). patients with symptomatic coronary artery disease without cardiogenic shock who will undergo coronary angiography and willing to participate in the trial will receive before the procedure a loading dose of p2y12 antagonists (clopidogrel, prasugrel or ticagrelor). eligible patients who do not meet the exclusion criteria and for whom pci will be considered as the appropriate form of revascularization will be randomly assigned to the orsiro or the xience prime des in the relation 1 x orsiro: 1 x xience prime. all patients will receive periprocedural intravenous aspirin and heparin or bivalirudin. after the intervention patients will receive aspirin indefinitely and p2y12 antagonists for at least 6 months. the intravascular imaging by oct will be performed at the 6-8 months follow-up angiography.

Eligibility criteria:
inclusion criteria: * patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% stenosis located in native coronary vessels. * written, informed consent by the patient or her/his legally-authorized representative for participation in the study. * in women with childbearing potential a negative pregnancy test is mandatory. * aha type a, b1 and b2 lesions. exclusion criteria: * lesion length \> 25 mm requiring a stent length \> 28 mm * target lesion located in the left main trunk. * in-stent restenosis. * acute myocardial infarction * malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 18 months or that may result in protocol non-compliance. * known allergy to the study medications: sirolimus, everolimus * inability to take dual antiplatelet therapy for at least 6 months. * the presence of bifurcation lesions * the presence of calcified lesions * pregnancy (present, suspected or planned) or positive pregnancy test. * previous enrollment in this trial. * patient's inability to fully cooperate with the study protocol
medtronic reveal linq™ in-office 2 (rio 2) study united states

Conditions: Arrhythmia

Summary: the primary purpose of the rio 2 study is to demonstrate that when the reveal linq™ insertable cardiac monitoring (icm) system that records subcutaneous ecg insertion procedure performed in the in-office setting is as safe as linq™ insertions performed in the traditional hospital setting (operating room, cardiac catheterization or electrophysiology (ep) laboratory).

rio 2 is a two arm, randomized, prospective, un-blinded, multicenter, non-significant risk study. the primary objective for rio 2 will be assessed by randomizing subjects to receive their linq™ insertion in the office setting or in the traditional hospital environment. moving the linq™ insertion procedure to the office setting is not expected to decrease the complication rate compared to in hospital insertion procedures, however, moving the linq™ insertion procedure out of the traditional hospital setting may benefit the patient and reduce the burden to the healthcare system.

Eligibility criteria:
inclusion criteria: 1. patient is indicated for continuous arrhythmia monitoring with a reveal linq™ insertable cardiac monitor 2. patient is 18 years of age or older 3. patient is willing to undergo icm insertion procedure outside of the cath lab, or, ep lab setting with only local anesthetic 4. patient is willing and able to provide consent and authorize the use and disclosure of health information 5. patient is willing and able to comply with the protocol including the required follow-up exclusion criteria: 1. patient has unusual thoracic anatomy or scarring at the implant site which may adversely affect the success of the implant procedure 2. patient has reduced immune function or is otherwise at high risk for infection per physician discretion 3. current therapy with immunosuppressive agents or chronic steroid use e.g. prednisone greater than 20mg per day 4. patient requires hemodialysis 5. patient with active malignancy or history of chemotherapy or radiation treatment patient has had a recent (within 30 days) or an active infection including but not limited to pneumonia, urinary tract, cellulitis, or bacteremia. 6. patient has had major surgery (in the past 6 months) 7. patient has undergone a procedure which required central venous or intraarterial access (e.g. af/vt ablation, ep study, coronary angio) within the last 3 months or is scheduled for such a procedure while enrolled in the study. 8. prior history of surgical infection, prosthetic device infection, or endovascular infection, including endocarditis, in the past 12 months. 9. patient has a central venous port, an atrio-venous fistula, or a prosthetic valve 10. patient requires conscious or moderate sedation to receive linq™ 11. patient is already implanted with a loop recorder 12. patient is implanted or indicated for implant with a pacemaker, icd, crt device 13. patient is enrolled in another study that could confound the results of this study, without documented pre-approval from a medtronic study manager. 14. patient's life expectancy is less than 6 months 15. patient is pregnant
effect of prp injection after arthroscopic meniscal repair in the healing process

Conditions: Knee Pain; Knee Injuries

Summary: the investigator's hypothesis was that intra-articular knee injection with prp in patients underwent arthroscopic meniscal repair and didn't receive intra-surgical prp, may add beneficial effect on post-meniscal repair outcomes regarding pain, functional state of the operated knee as well as healing process.

the study was done on 30 patients underwent arthroscopic isolated meniscal repairs performed by a single surgeon but unfortunately didn't receive prp injection during the repair procedure. random, double blinded selection of 15 patients to constitute the prp-group was injected intra-articularly with about 5 ml of prp in the operated knee joint. the other fifteen patients were not injected and constituted control group. prp preparation: thirty ml of venous blood was taken from every patient and collected in sodium citrated sterile tubes. platelet concentrates obtained by adjusting centrifuge at 1800 rpm for 15 min to separate erythrocytes, then at 3500 rpm for 10 min to concentrate the platelets. the preparation was done by a single laboratory technician. thus 5 ml of prp were obtained, 0.2 ml of 10% calcium chloride was added to the final product to activate the platelets and injected immediately without storage. procedure pre-injection guidelines were given to all patients (in prp group) in the form of stopping steroidal and non-steroidal anti-inflammatory drugs for at least one week before the procedure, as well as stopping any anticoagulant drugs 5 days before the procedure, increasing intake of fluids within the 24 hours prior to the procedure and anti-anxiety medication were required for anxious patients. injection, under complete aseptic techniques, was performed while the patient was in supine position, and the knee was fully extended, using the lateral approach. patients were instructed after injection to avoid using the injected leg for 24 hours, to use ice packs over the injected joint and not to use nsaids for another one week.

Eligibility criteria:
inclusion criteria: * patients aged 18-55 years * complete meniscal tear in red-white zone done repaired * surgery was done by by a single surgeon exclusion criteria: * some systemic disorders, such as diabetes, autoimmune diseases, hematological disorders, cardiovascular diseases, infections * local knee injuries other than meniscal injury * patients receiving treatment with anticoagulants-anti-aggregates * use of nsaids within 5 days before local prp injection.

Keywords: prp regeneration ultrasound
irreversible electroporation(ire) for unresectable stomach neoplasms

Conditions: Stomach Neoplasms

Summary: the purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (ire) for unresectable stomach neoplasms.

by enrolling patients with unresectable head and stomach adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous ire for unresectable stomach neoplasms.

Eligibility criteria:
inclusion criteria: * stomach neoplasms diagnosed by positive biopsy or non-invasive criteria, * not suitable for surgical resection, * eastern cooperative oncology group (ecog) score of 0-1, * a prothrombin time ratio \> 50%, * platelet count \> 80x10\^9/l, * ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post nanoknife procedure, * able to comprehend and willing to sign the written informed consent form (icf), * have a life expectancy of at least 3 months. exclusion criteria: * cardiac insufficiency, ongoing coronary artery disease or arrhythmia, * any active implanted device (eg pacemaker), * women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception, * have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the nanoknife™ ledc system, * are in the opinion of the investigator unable to comply with the visit schedule and protocol evaluations.

Keywords: irreversible electroporation unresectable stomach neoplasms
the safety and efficacy of the suture-mediated closure system

Conditions: Peripheral Arterial Disease; Arterial Puncture

Summary: this was a prospective, multicenter, randomized, controlled, non-inferiority clinical study with the primary objective of validating the safety and efficacy of the suture-mediated closure system for percutaneous closure of the common femoral artery puncture site.

this study was a prospective, multicenter, randomized, controlled, non-inferiority clinical trial. it is planned to be conducted in multiple clinical trial institutions and enroll 228 subjects. eligible subjects were randomly divided into the experimental group or the control group at a ratio of 1:1.

Eligibility criteria:
inclusion criteria: * between 18 years old and 85 years old, randomized * patients who can be examined or treated with a common femoral artery puncture interventional catheter using a 5f to 22f sheath tube * patient(or their guardians) who submitted a written informed consent for the this trial exclusion criteria: * known to be pregnant or lactating * the diameter of femoral artery on the puncture side was less than 5mm * patients requiring anterograde puncture approach * have participated in or plan to participate in another clinical trial in the same period * known allergy to any components of the device, and/or contraindications to contrast agents and anticoagulants * international normalized ratio (inr) \>2.0 * traumatic vascular injury at the approach site * systemic or local groin infection * cerebrovascular accident or myocardial infarction within 3 months * an arterial catheter needs to be placed at the access site * morbidly obese (bmi ≥40 kg/m2) * the entire common femoral artery wall assessed by ultrasound, calcification located in the anterior wall cut, the extent of more than 50% circumferential or common femoral artery stenosis ≥50 * femoral artery aneurysm, arteriovenous fistula or pseudoaneurysm in common femoral artery * using a clip vessel occluder at the past ipsilateral femoral artery access site * use of a puncture point occlusion device at the ipsilateral femoral access site within the past 30 days * underwent an intervention via ipsilateral femoral artery puncture within the past 30 days or within the next 30 days * ipsilateral femoral vein sheath needed to be used * evidence of previous common femoral artery surgery on the same side (e.g., inguinal incision) * hematoma at ipsilateral arterial access * other circumstances that the investigator deemed inappropriate for participation in the trial.femoral artery aneurysm, arteriovenous fistula or pseudoaneurysm in common femoral artery
video-based patient navigation to support cervical cancer screening among black women

Conditions: Uterine Cervical Neoplasms

Summary: the goal of this clinical trial is to test whether an interactive, video-based patient navigation program can improve cervical cancer screening among african american women who are currently overdue for screening. the main questions it aims to answer are: can an interactive video navigation tool (mnav), when paired with in-person navigation, improve screening adherence compared to a standard educational video alone? does the intervention improve knowledge, reduce barriers, and increase intentions to get screened? researchers will compare participants who receive both the interactive video (guided by an on-screen navigator) and in-person navigation to those who receive only a standard educational video to see if the tailored support increases screening rates. participants will: complete two phone surveys (one at the beginning and one six months later) be randomly assigned to one of two groups: one group will receive an interactive video experience tailored to their concerns plus support from an in-person navigator the other group will receive a standard educational video designed for african american women have their clinic records reviewed six months later to check for cervical cancer screening completion


Eligibility criteria:
inclusion criteria: * black or african american woman * nonadherent to uspstf cervical cancer screening guidelines (no pap test in the past 3 years or no hpv test in the past 5 years) * age 21 to 65 years old * not currently pregnant * no history of hysterectomy * access to a mobile phone capable of receiving text messages and watching video content exclusion criteria: \*none

Keywords: early detection of cancer health behavior patient navigation african americans
the evaluation of ankle joint braces efficiency

Conditions: Ankle Injuries; Ankle Sprains

Summary: the project concerns the evaluation of commercially available ankle joint braces effectiveness used as orthopedic supply after ankle joint ligaments tear injury. authors hypothesize that the restriction of range of motion may be not sufficient in the early healing process.


Eligibility criteria:
inclusion criteria: * age 18-35 * female or male * good health condition * chronic ankle joint instability (for chronic ankle instability group) exclusion criteria: * lower limb injuries (last 6 months) * extreme sports athletes * no chronic ankle joint instability (for chronic ankle instability group)

Keywords: ankle joint brace atfl oxford foot model
peripheral effects of endotoxin on insulin resistance

Conditions: Healthy

Summary: the aim of the study is to isolate the direct effects of endotoxin on glucose, lipid and protein metabolism. eight healthy volunteers are enrolled. the hypothesis is that endotoxin will induce insulin resistance, lypolysis and proteolysis acutely.


Eligibility criteria:
inclusion criteria: 1. normal health 2. 22 \< bmi \< 28 3. written informed concent exclusion criteria: 1. any disease 2. any use of medication 3. recent immobilization of a lower extremity

Keywords: endotoxin insulin resistance lipolysis proteolysis intracellular insulin signaling regional effects of inflammation/endotoxin
nitrous oxide for the treatment of major depressive disorder

Conditions: Depression; Major Depressive Disorder

Summary: the investigators are conducting a randomized controlled trial to evaluate the antidepressant effects of nitrous oxide in people with major depressive disorder (mdd). mdd is a global medical condition that causes significant health and economic burden. recent studies have shown that a single dose of ketamine, an nmda-antagonist, has fast and long lasting anti-depressant effect. nitrous oxide, another nmda-antagonist, is widely used for anesthesia and analgesia, safer to administer and has fewer side effects than ketamine. a randomized controlled crossover feasibility study showed significant reduction in depressive symptoms at 2 and 24 hours after a single 1-hour treatment session of inhaled nitrous oxide compared with placebo. nitrous oxide is inexpensive and can be safely administered by any trained clinician. if found to be efficacious, it could be used to provide rapid anti-depressant effect whilst the benefit of traditional anti-depressants has its delayed effect. another potential application could be in acutely suicidal patients. this investigated-initiated phase 2b trial will enable confirmation and extension of the findings from the feasibility study, and identify the optimal dose and regimen in a broader population of those with mdd. participants will be randomized to receive a weekly 1-hour inhalational sessions of either nitrous oxide or placebo (oxygen-air mixture) for 4 weeks, and the nitrous group will be further randomly assigned to a dose of 50% nitrous oxide or 25% nitrous oxide. depression severity will be assessed by a blinded observer pre-treatment and at weekly intervals during and for 4 weeks after treatment using the hamilton depression rating scale.


Eligibility criteria:
inclusion criteria: 1. adult (≥18 years, both sexes), with dsm-iv-tr criteria for mdd without psychosis, as determined using a structured clinical interview \[mini international neuropsychiatric interview\] 2. mdd, as defined by a pretreatment score \>18 on the hdrs-21 scale exclusion criteria: 1. a history of bipolar disorder, schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, panic disorder, or documented axis ii diagnoses; active suicidal intention, as determined by clinical interview 2. active or recent (\<12 months) substance abuse or dependence; excluding nicotine 3. administration of nmda-antagonists (e.g., ketamine) in previous 3 months 4. ongoing treatment with ect 5. presence of acute medical illness that could interfere with study participation, including significant pulmonary disease 6. pregnancy or breastfeeding 7. any contraindications to the use of nitrous oxide (e.g., pneumothorax, middle ear occlusion, elevated intracranial pressure, chronic cobalamin or folate deficiency unless treated with folic acid or vitamin b12).

Keywords: depression depressive disorder, major mood disorders mental disorders nitrous oxide anesthetics, inhalational anesthetics anesthetics, general physiologic effects of drugs analgesics, non-narcotic analgesics
exacerbations and real-world outomes including cardiopulmonary events among patients with chronic obstructive pulmonary disease (mitos: eros+cp us study)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: a retrospective real-world data study, assessing the relationship between the timing of budesonide/glycopyrrolate/formoterol initiation following an exacerbation and the occurrence of subsequent exacerbations, severe cardiopulmonary events and other real-world outcomes in the united states


Eligibility criteria:
inclusion criteria: * 1 prescription(s) fill for bgf on or following july 24, 2020 (date of bgf approval in the united states) * patients must have evidence a qualifying exacerbation events which, per local or global guidelines, would qualify a patient to have treatment escalated or initiated to triple therapy. the qualifying exacerbation event must occur within the 12-month period preceding the initiation of bgf but occurring on or following local bgf commercial availability (july 24, 2020) and includes either of the following * 12 months of continuous health plan enrollment preceding the qualifying index exacerbation event date ('baseline' period) * 1 day of continuous enrollment following the qualifying index exacerbation date * age ≥ 40 years on the qualifying index exacerbation event exclusion criteria: * presence of cancer diagnoses other than basal or squamous cell skin cancer during the baseline or follow-up periods * presence of interstitial fibrosis, sarcoidosis, or pulmonary embolism diagnoses during the baseline or follow-up periods * presence of triple therapy sitt during the baseline period through bgf initiation

Keywords: copd chronic obstructive pulmonary disease retrospective real-world effectiveness
follow-up of persons with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: multiple sclerosis (ms) is a chronic, progressive and demyelinating disease that affects more than 2.5 million people in the world and is frequently seen in young adults between 20 and 40 years of age, especially in women. although the exact ms in turkey is not known, it is estimated as 40/100,000. according to epidemiological studies in recent years, the prevalence and incidence of ms tend to increase. the most common clinical signs and symptoms include loss of sensation in the extremities, partial or total vision loss, acute or subacute motor dysfunction, cognitive impairment, double vision and gait dysfunction. currently, ms has no definitive cure. progressive symptoms related to the disease need to be managed in order to increase and maintain the quality of life of individuals with ms. pharmacological, physiotherapeutic and psychotherapeutic methods are the most effective effective methods in the management of symptoms. however, the efficacy of these methods has been demonstrated in clinical trials. the outcomes cannot be generalized to the entire ms population because of the inclusion and exclusion criteria that exist in clinical trials. in addition, clinical trials are conducted at a specified time interval (usually a short time interval is selected) and generally, short-term results are provided. in order to better understanding the course of ms, it is of utmost importance that long-term follow-up studies are carried out where as many patients are included and patients are followed from the date of initial diagnosis. the aim of this study is to investigate the change of physical, psychosocial and cognitive characteristics over time and the correlated variables. the volunteers from ms patients who attend routine control of the ms outpatient clinic of dokuz eylül university hospital will participate in the study. physical and clinical assessments will be performed by physicians and physiotherapists, and cognitive evaluations will be performed by psychologists with 6-month intervals.


Eligibility criteria:
inclusion criteria: * diagnosis of multiple sclerosis * willingness to participate exclusion criteria: * severe cognitive, physical, or psychiatric disability that prevent the assessments
pharmacokinetic study to compare the blood levels of low vs high metal manufacture of abatacept

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to determine whether the blood levels of abatacept drug product manufactured using high metals and using low metals are comparable in healthy subjects.

compare the pharmacokinetic (pk) of high metals abatacept relative to low metals abatacept following a single intravenous infusion of 750 mg in healthy subjects.

Eligibility criteria:
inclusion criteria: * healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ecgs, and clinical laboratory determinations * body weight will be between 60 and 100 kg, inclusive exclusion criteria: * any significant acute or chronic medical illness * any major surgery within 4 weeks of study drug administration * smoking more than 10 cigarettes per day * recent (within 6 months of study drug administration) drug or alcohol abuse * positive blood screen for hepatitis c antibody, hepatitis b surface antigen, or hiv-1, -2 antibody * history of any significant drug allergy or asthma * women who are pregnant or breastfeeding and/or unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period